Catalog Number

156219

Brand Name

ViroMax

Version/Model Number

ViroMax - 156219

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K063526,K063526

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

73bf0feb-3889-45d6-9db0-9d91af332fe3

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

00817081027280

Quantity per Package

50

Contains DI Package

00817081027273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-